NCT05855317

Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS

Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
OTHER	Blood sample	Additional blood samples will be taken on a catheter, used for standard care.

Timeline

• Start date: 2023-10-31
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2023-05-11
• Last updated: 2026-02-04

Locations

1 site across 1 country: France